Department of Diagnostic Radiology and Biomedical Imaging, Yale School of Medicine, 333 Cedar St, TE2, New Haven, CT 06520.
AJR Am J Roentgenol. 2022 Jul;219(1):152-156. doi: 10.2214/AJR.21.27224. Epub 2022 Feb 9.
Proponents of artificial intelligence (AI) technology have suggested that in the near future, AI software may replace human radiologists. Although assimilation of AI into the specialty has occurred more slowly than predicted, developments in machine learning, deep learning, and neural networks suggest that technologic hurdles and costs will eventually be overcome. However, beyond these technologic hurdles, formidable legal hurdles threaten the impact of AI on the specialty. Legal liability for errors committed by AI will influence the ultimate role of AI within radiology and also influence whether AI remains a simple decision support tool or develops into an autonomous member of the health care team. Additional areas of uncertainty include the potential application of products liability law to AI and the approach taken by the U.S. FDA in potentially classifying autonomous AI as a medical device. The current ambiguity of the legal treatment of AI will profoundly influence development of autonomous AI given that vendors, radiologists, and hospitals will be unable to reliably assess their liability associated with implementing such tools. Advocates of AI in radiology and health care in general need to lobby for legislative action to better clarify the liability risks of AI in a way that does not deter technologic development.
人工智能（AI）技术的支持者曾表示，在不久的将来，AI 软件可能会取代人类放射科医生。尽管 AI 融入该专业的速度比预期的要慢，但机器学习、深度学习和神经网络的发展表明，技术障碍和成本最终将被克服。然而，除了这些技术障碍之外，强大的法律障碍也威胁着 AI 对该专业的影响。AI 所犯错误的法律责任将影响 AI 在放射科的最终作用，也将影响 AI 是仍然只是一个简单的决策支持工具，还是发展成为医疗保健团队的自主成员。其他不确定领域包括产品责任法对 AI 的潜在应用，以及美国食品和药物管理局（FDA）在将自主 AI 潜在归类为医疗器械方面所采取的方法。鉴于供应商、放射科医生和医院将无法可靠地评估与实施此类工具相关的责任，目前对 AI 的法律处理的模糊性将对自主 AI 的发展产生深远影响。放射科和整个医疗保健领域的 AI 倡导者需要游说立法行动，以更好地澄清 AI 的责任风险，而不会阻碍技术发展。
